Atlas FDA

DCF

37 FDA 510(k) clearances · Product code

66 daysmedian time to decision
255 days90th percentile
37clearances measured

FDA profile

Official device name
Albumin, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5040
Medical specialty
Immunology
Adverse events (MAUDE)
1997: 1 · 2026: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Optilite Low Level Albumin Kit (K153560)The Binding Site Group , Ltd.2016-08-25
Human Microalbumin kit for use on SPAPLUS (K143118)The Binding Site Group , Ltd.2015-05-26
Urine/CSF Albumin, Urine/CSF Albumin Calibrator (K142346)Beckman Coulter Ireland, Inc.2014-10-15
HUMAN ALBUMIN CSF KIT (K121045)The Binding Site Group , Ltd.2013-06-19
TINA-QUANT ALBUMIN GEN.2 (K113072)Roche Diagnostics Operations2012-05-14
EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR (K101089)Medica Corp.2011-07-13
TINA-QUANT ALBUMIN GEN 2 (K101203)Roche Diagnostics2010-09-10
COBAS 8000 MODULAR SERIES ANALYZER (K100853)Roche Diagnostics Corp.2010-09-09
K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR (K091486)Kamiya Biomedical Co.2010-04-29
SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100 (K082251)Beckman Coulter, Inc.2009-04-08
DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 CALIBRATOR; PROTEIN 3 CONTROL (K061990)Dade Behring, Inc.2006-09-19
NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL (K053553)Polymedco, Inc.2006-03-09
DCL MICROALBUMIN ASSAY, MODEL 252-20 (K051191)Diagnostic Chemicals , Ltd.2005-07-05
VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II (K042643)Ortho-Clinical Diagnostics, Inc.2004-11-18
DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114 (K033525)Dade Behring, Inc.2004-01-12
N ANTISERUM TO HUMAN ALBUMIN (K972929)Behring Diagnostics, Inc.1997-10-20
IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT (K964695)Beckman Instruments, Inc.1997-04-29
COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN (K961824)Roche Diagnostic Systems, Inc.1996-07-23
LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM (K953927)International Enzymes, Inc.1995-09-15
ALBUMIN TEST RID KIT (K914391)The Binding Site, Ltd.1991-12-10
TURBIQUANT IMMUNOGLOBULIN & ALBUMIN KIT (K900167)Behring Diagnostics, Inc.1990-01-22
MODIFIED QM300 ALBUMIN ANTIBODY PACK (K896059)Kallestad Diag, A Div. of Erbamont, Inc.1989-11-06
TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN (K895808)Technicon Instruments Corp.1989-10-17
TECHNICON DPA-1(TM) SYSTEM (K882153)Technicon Instruments Corp.1988-08-04
QM300 ALBUMIN ANTIBODY PACK (K882082)Kallestad Diag, A Div. of Erbamont, Inc.1988-07-08
QM300 CALIBRATOR D PACK (K881127)Kallestad Diag, A Div. of Erbamont, Inc.1988-04-21
QM300 ALBUMIN ANTIBODY PACK (K881126)Kallestad Diag, A Div. of Erbamont, Inc.1988-04-06
MAT (TM) MICROALBUMIN TEST (K875161)Wampole Laboratories1988-02-17
ALBUMIN IN SERUM (K873862)Unipath , Ltd.1987-10-20
ALBUMIN IN URINE (K873861)Unipath , Ltd.1987-10-13
MICROALBUMINURIA ASSAY (K862671)Orion Corp.1986-09-18
RADIAL IMMUNODIFFUSION PLATES CSF IGG & CSF ALBUMI (K851285)Cooper Biomedical, Inc.1985-06-17
IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALBUM (K812496)Dako Corp.1981-09-23
ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE (K802404)Ortho Diagnostics, Inc.1980-10-23
ADDITIONAL REAGENTS KITS FOR IMM. SYSTEM (K780913)Beckman Instruments, Inc.1978-06-22
QUAN. COLOR. DETER. OF SERUM ALBUMIN (K771771)Stanbio Laboratory1977-10-07
LOW LEVEL HUMAN ALBUMIN TEST KITS (K761225)Intl. Diagnostic Technology1977-04-07

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Every clearance here is in the API, with alerts when new ones post.